Syneos Health is hiring for the Safety & PV Coordinator – Clinical Trial Case Processing position. The role focuses on pharmacovigilance, Individual Case Safety Report (ICSR) processing, safety data review, regulatory reporting, and clinical trial safety documentation.
Candidates with at least 1 year of experience in clinical trial case processing, including adverse event case handling and pharmacovigilance activities, can review the eligibility criteria and apply through the company’s official careers portal.
Job Details
| Particulars | Details |
|---|---|
| Company | Syneos Health |
| Job Title | Safety & PV Coordinator – Clinical Trial Case Processing |
| Job Requisition ID | 25110338 |
| Work Arrangement | Office-based |
| Employment Type | Full-time |
| Experience | 1+ year |
| Qualification | Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or equivalent relevant education and experience |
| Job Category | Pharmacovigilance / Clinical Trial Case Processing |
Position Overview
The Safety & PV Coordinator supports clinical trial and post-marketing pharmacovigilance activities by processing safety cases, reviewing adverse event data, maintaining safety tracking systems, and supporting regulatory reporting. The position also involves medical coding, ICSR quality review, duplicate case management, and compliance with applicable safety reporting requirements.
Key Responsibilities
- Enter and track Individual Case Safety Reports (ICSRs) in pharmacovigilance quality and tracking systems.
- Process and triage ICSRs, assess data completeness and accuracy, and enter case information into safety databases.
- Code adverse events, medical history, concomitant medications, and medical tests.
- Prepare narrative summaries, identify missing information, and follow up on queries until they are resolved.
- Support timely and accurate expedited safety reporting in accordance with applicable regulatory requirements.
- Maintain safety trackers and perform literature screening and safety reviews.
- Perform MedDRA coding, drug dictionary maintenance, and manual recoding of product and substance terms.
- Validate and submit xEVMPD product records and support SPOR/IDMP-related activities.
- Identify and manage duplicate ICSRs and perform quality reviews of safety cases.
- Ensure relevant documentation is submitted to the Trial Master File (TMF) and Pharmacovigilance System Master File, as applicable.
- Follow SOPs, Work Instructions, ICH-GCP, GVP, and applicable global drug, biologic, and device regulations.
- Participate in audits and apply safety reporting regulatory intelligence to assigned activities.
Eligibility and Qualifications
Applicants should meet the following requirements:
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or an equivalent combination of education and experience.
- At least 1 year of experience in clinical trial case processing.
- Experience handling adverse event cases, reviewing safety data, and performing pharmacovigilance activities.
- Experience with safety database systems.
- Knowledge of medical terminology.
- Understanding of clinical trial processes across Phases II–IV and/or post-marketing safety requirements.
Required Skills
- Individual Case Safety Report (ICSR) processing
- Pharmacovigilance and adverse event case handling
- Safety database management and safety data review
- MedDRA coding and drug dictionary maintenance
- xEVMPD validation and submission
- SPOR/IDMP activities
- ICH-GCP, GVP, and safety reporting regulations
- Microsoft Word, Excel, PowerPoint, Visio, and Outlook
- Shared content and workspace management tools
- Written and verbal communication
- Organization, prioritization, and multitasking
- Attention to detail and accuracy
- Ability to work independently and collaboratively
